Biosimilars agreements for Hospira and mAbxience
Posted 03/05/2013

In line with Hospira’s strategy of expansion into biosimilars, the injectable generics specialist announced on 29 April 2013 that it had entered into a collaborative arrangement for several biosimilar products with NovaQuest Co-Investment Fund I, L.P. (NovaQuest).

The agreement covers Hospira’s biosimilar erythropoietin (in Canada and the US), filgrastim (in the US) and pegylated filgrastim (globally). Hospira will be responsible for development, regulatory approval, commercialization and distribution of the biosimilars. NovaQuest, on the other hand, will contribute up to US$150 million of development funding, with Hospira funding the remaining development costs.

Hospira already sells a biosimilar erythropoietin (Retacrit) in Europe and has launched a biosimilar version of filgrastim (Nivestim) in Australia [1]. The company has also carried out a successful phase I trial for biosimilar erythropoietin in the US comparing it to Amgen’s blockbuster anaemia drug, Epogen [2]; and it is currently conducting a phase III US clinical trial programme [3]. The company has other biosimilars agreements in place with Celltrion, Human Genome Sciences and Stada [1].

mAbxience, the biosimilar division of Swiss firm Chemo SA Lugano, announced on 23 April 2013 that it had signed an agreement with Brazil-based Libbs Farmacêutica (Libbs) for mAbxience to produce seven biosimilars.

Libbs will invest US$100 million in the construction of a manufacturing site in São Paulo, Brazil, expected to be ready by 2016, which will produce the biosimilars. Until then the companies have agreed that mAbxience will export the drugs to Libbs from its plant in Argentina.

The terms of the agreement include milestone and royalty payments from Libbs to mAbxience, as well as collaboration in clinical trials.

The biological drug market in Brazil is the most important in the region, with sales for the main compounds reaching US$1,000 million annually.

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